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Clinical Trials in China / NCT05789043
Recruiting Phase 3

Camrelizumab in Combination With Apatinib and Temozolomide as First-line Treatment in Advanced Acral Melanoma

NCT05789043 · tracked via the Priya Life Science China tracker
Sponsor
Peking University Cancer Hospital & Institute
Phase
Phase 3
Started
2023-03-21
Last updated
2023-09-06

Condition(s) studied

Acral Melanoma

Investigational drug(s) / intervention(s)

camrelizumab+apatinib+TMZcamrelizumab+apatinibcamrelizumab

camrelizumab+apatinib+TMZ: camrelizumab 200mg,q2w+apatinib 250mg,qd+TMZ 200mg/m2,day1-5/28

camrelizumab+apatinib: camrelizumab 200mg,q2w+apatinib 250mg qd

camrelizumab: camrelizumab 200mg,q2w

Study summary

It is a RCT aimed to evaluate the Progression Free Survival of Camrelizumab combined with apatinib and temozolomide as First Line Therapy in Advanced Acral Melanoma.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
Inclusion Criteria: * age:≥18 years, male or female. * Histopathologically confirmed recurrence, inoperable resection or metastatic acral melanoma (stage III/IV). * Has not received any systematic anti-tumor drug treatment. * Measurable disease based on Response Evaluation Criteria In Solid Tumors (RECIST) 1.1. * ECOG 0-1. * Adequate organ function. * Life expectancy of greater than 12 weeks. * Patient has given written informed consent. Exclusion Criteria: * Patients who have or are currently undergoing additional chemotherapy, radiation therapy, targeted therapy or immunotherapy. * Known history of hypersensitivity to macromolecular protein preparation or any components of the drug formulation. * Subjects before or at the same time with other malignant tumors (except which has cured skin basal cell carcinoma and cervical carcinoma in situ); * Subjects with any active autoimmune disease or history of autoimmune disease Uncontrolled clinically significant heart disease, including but not limited to the following: (1) \> NYHA II congestive heart failure; (2) unstable angina, (3) myocardial infarction within the past 1 year; (4) clinically significant supraventricular arrhythmia or ventricular arrhythmia requirement for treatment or intervention; * Received a live vaccine within 4 weeks before the first dose of study medication. * Pregnancy or breast feeding. * Decision of unsuitableness by principal investigator or physician-in charge.

Primary outcome measure(s)

Trial sites (1)

FacilityCityRegionStatus
Beijing Cancer Hospital Beijing China Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05789043 on ClinicalTrials.gov ↗ ← All trials in China